Health TrialsbyHealthPanel

Digital Inhaler Use in Obstructive Lung Disease Care

ConditionsChronic Obstructive Airways Disease ExacerbatedChronic Obstructive Airway Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCedars-Sinai Medical Center

About this trial

This is a pilot study to evaluate the role digital inhaler technology on patients with obstructive lung disease in preventing admissions and exacerbation, as well as improving symptom control. The primary objective is to evaluate feasibility of study protocol, patient recruitment, and patient retention with goal recruitment of 20 participants, 60% recruitment success, and 60% retention rate for 6 months duration. The secondary objectives are the evaluation of patient admission rate, exacerbation rates, and symptoms control with use of digital inhaler technology The subject population will be patients with physician diagnosed obstructive lung disease.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Any sex

Over the age of 18 years.

Physician-diagnosed obstructive lung disease

Speak, read, and understand English.

Disqualifiers

Physically disabled such that they are incapable of using digital devices or metered dose inhalers.

Suffer from any visual, hearing or cognitive impairment that cannot be corrected enough to operate the devices properly. Mild/moderate vision loss and mild hearing loss may be included with appropriate corrective measures that do not affect the device usage.

Suffering from serious uncontrolled medical conditions that may interfere with study conduct.

Inability or unwillingness of the participant to give written informed consent.

Trial design

Design model

Single group

Treatments tested in this trial

  • Digital Inhaler Attachment

    Device

    This intervention is the attachment of a digital device to provide patient with coaching for optimal inhaler use and technique, as well as monitoring of patient use of inhaler to patient and health care team. Patient will continue to use inhalers prescribed as per usual care for management of COPD.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Digital Inhaler Attachment for Regular CareOther 1 intervention

Trial outcomes

Primary outcomes

1

Participant Recruitment Percentage

The investigators will be looking at what percentage of patients approached for recruitment choose to participate in the study. Accrual rate will be computed as the proportion of subjects enrolled as a function of the number of subjects screened.

Time frame
6 months
2

Participant Retention Percentage

The investigators will also be looking at what percentage patient who choose to participate remain participating for the full 6-month duration of the study period. The retention rate over the full 6-month period of follow-up will be computed among enrolled subjects.

Time frame
6 months

Secondary outcomes

1

Re-admission Rate

Hospital re-admission rate for COPD exacerbation during study period

Time frame
6 months
2

COPD Exacerbation Rates

Rates of COPD exacerbation after intervention during study period

Time frame
6 months
3

Symptom Control

Overall symptoms control of COPD after intervention during study period. This will utilize the COPD Assessment Test. Scores with this test can range from 0 to 40, with higher score representing worse severity of disease and worse symptom control.

Time frame
6 months
4

Satisfaction with Device Assessed with Questionnaire

Assessment of patient satisfaction with use of device utilizing questionnaire to be administered at the conclusion of the study.

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cedars-Sinai Medical Center

Lead sponsor

Breathe California, Los Angeles County

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: